Active — Not RecruitingPhase 3

Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study

United States1,175 participantsStarted 2019-06-07

Plain-language summary

This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * STEP I REGISTRATION CRITERIA * Histologically documented renal cell carcinoma with clear cell component, including patients who have sarcomatoid or rhabdoid features * Any metastatic disease, including visceral, lymph node, other soft tissue and bone, measurable per RECIST 1.1 * Measurable disease as defined in the protocol * Must be intermediate or poor risk patient per International Metastatic Renal Cell Carcinoma Database (IMDC) criteria (1 or more of the following): Karnofsky performance status \[KPS\] \< 80, \< 1 year from diagnosis \[including initial nephrectomy\] to systemic treatment for metastatic disease, hemoglobin less than lower limit of normal \[LLN\], corrected calcium concentration greater than upper limit of normal \[ULN\], absolute neutrophil count greater than ULN, platelet count \> ULN) * Central nervous system (CNS) disease permitted, if stable and not otherwise causing symptoms or needing active treatment * Karnofsky performance status \>= 70% * No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents (including but not limited to nivolumab, pembrolizumab, pidilizumab, durvalumab, atezolizumab, tremelimumab, and ipilimumab), or any other drug or antibody specifically targeting T-cell co-stimulation or checkpoint pathways. The only exception is for prior treatment with nivolumab or other PD-1/PD-L1/CTLA-4 targeting therapy on pre- or post-operative trials, as long as \> 1 year since completion of systemic therapy * No prior …

What they're measuring

Overall survival (OS)

Timeframe: From registration to date of death from any cause for non-randomized patients, from time of randomization until death from any cause for randomized patients, assessed up to 5 years

Trial details

NCT IDNCT03793166

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2028-01-25